Solid TumorPhase 1NCT07358806
Study to Assess the Effect of OCT-598 in Patients With Advanced Solid Tumors
A Phase 1 study testing OCT-598 and Docetaxel in people with Solid Tumor and Breast Cancer, run by Oscotec Inc. at 3 sites in South Korea.
Trial summary
This is a Phase 1 study intended to determine the MTD of OCT-598 following multiple-dose therapy and to establish the RP2D for OCT-598 as a single agent, by assessing its safety and tolerability as monotherapy and in combination with standard-of-care treatments in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Breast Cancer, Head and Neck Cancer
- What is being tested?
- OCT-598 and Docetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 18 Dec 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male, ≥18 years of age (or ≥19 years according to according to the local regulatory guidance), at the time of screening
- Signed informed consent prior to any study-related procedures that are not considered standard of care
- Life expectancy >12 weeks in the opinion of the investigator
- Adequate organ and marrow function, defined as follows:
- Absolute neutrophil count ≥1.5 × 109/L
- Platelets ≥100,000/μL
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- Hemoglobin ≥9.0 g/dL
- Total bilirubin <1.5 × ULN
- ALT or AST ≤2.5 × ULN
- Creatinine clearance calculated using the Cockcroft-Gault formula ≥60 mL/min (In equivocal cases, a 24-hour urine collection test can be used to estimate the creatinine clearance more accurately)
- LVEF >50% or within institutional values
- At least 1 measurable lesion based on RECIST version 1.1
- Cohort-specific disease requirements:
- Part A: patients with advanced solid tumors and no effective standard therapy option or for whom standard-of-care treatment is not available or not appropriate as per the investigator's discretion
- Part B: patients with advanced solid tumors who are candidates for receiving docetaxel as a single agent for their cancer treatment, including but not limited to: advanced human epidermal growth factor receptor 2-negative breast cancer, recurrent/metastatic head and neck cancer, non-small cell lung cancer, prostate cancer, or gastric/gastroesophageal cancer
- Docetaxel-appropriate (Part B): patients who have not received prior docetaxel in the advanced setting are eligible
Who cannot join
- Treatment with any IP or other anticancer therapy (including chemotherapy, antibody-drug conjugates, targeted agents, and immunotherapy) within 28 days or 5 half-lives, whichever is longer, of the first dose of study drug.
- Prior clinically significant treatment-related toxicities not resolved to Grade ≤1 or baseline (per CTCAE version 5.0) except for alopecia. Participants with stable Grade 2 peripheral neuropathy or endocrinopathies with stable endocrine replacement therapy are eligible. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study treatment (eg, vitiligo or hearing loss) may be eligible after discussion with the Sponsor.
- Prior treatment with an EP2 and/or EP4 antagonist.
- Major surgery or wide-field radiation within 28 days or limited field palliative radiation within 7 days prior to the first dose of the study drug.
- Known active central nervous system metastasis. Patients with asymptomatic previously treated brain metastasis are eligible if they are clinically stable for at least 4 weeks prior to enrollment and do not require treatment with corticosteroids.
- Treatment with systemic corticosteroids at a dose of >10 mg of prednisone or equivalent at the time of enrollment, or any other immunosuppressive medication 7 days before the first dose of the study drug. Premedication with corticosteroids prior to chemotherapy administration in the combination phase is allowed, as per the site standard of care. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of study drug (acetylsalicylic acid ≤160 mg/day, or 325 mg ≤3 times/week is permitted).
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- Patients who are pregnant, breastfeeding, or planning to become pregnant during the study .
- Concomitant active malignancy or previous malignancy within 2 years of the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ or the cervix or breast, stage 1 prostate cancer, or other malignancy deemed to be cured by prior therapy in the judgment of the investigator may enroll regardless of the time of diagnosis.
- History of bleeding disorders, including gastrointestinal bleeding. Subjects with prior gastrointestinal bleeding due to the primary tumor, that is currently controlled, are allowed to participate.
- Mean resting corrected QT (QTc) interval using Fridericia's formula (QTcF) >470 ms, regardless of gender, or history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome). Patients with left bundle block or atrial fibrillation are eligible if QTc cannot be accurately calculated provided that there is no prior history of prolonged QTc.
- For patients in Part B only: AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
National Cancer Center
Goyang-si
Doctor, 82316287627, p1401@oscotec.com
- Recruiting
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si
Doctor, 82316287627, p1401@oscotec.com
- Not yet recruiting
Asan Medical Center
Seoul
Doctor, 82316287627, p1401@oscotec.com
About this study
Official title: A Phase 1 Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OCT-598 as a Single Agent and in Combination With Standard-of-Care Treatment in Patients With Advanced Solid Tumors
This is a Phase 1 study intended to determine the MTD of OCT-598 following multiple-dose therapy and to establish the RP2D for OCT-598 as a single agent, by assessing its safety and tolerability as monotherapy and in combination with standard-of-care treatments in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Breast Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Gastric/Gastroesophageal Junction Cancer
- Being tested
- OCT-598, Docetaxel
- Keywords
- EP2/EP4 antagonist
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-598Drug
OCT-598 will be administered orally once daily.
DocetaxelCombination product
Docetaxel will be provided for Part B only to support the combination therapy with the standard-of-care regimen.
| Study group | Role | What they receive |
|---|---|---|
| PART A. OCT-598 100mg QD | Experimental | Administered orally Receives: Drug: OCT-598 |
| PART A. OCT-598 200mg QD | Experimental | Administered orally Receives: Drug: OCT-598 |
| PART A. OCT-598 300mg QD | Experimental | Administered orally Receives: Drug: OCT-598 |
| PART A. OCT-598 500mg QD | Experimental | Administered orally Receives: Drug: OCT-598 |
| PART A. OCT-598 800mg QD | Experimental | Administered orally Receives: Drug: OCT-598 |
| PART A. OCT-598 1200mg QD | Experimental | Administered orally Receives: Drug: OCT-598 |
| PART B. OCT-598 DL1 QD | Experimental | Administered orally, Combination with Docetaxel Receives: Drug: OCT-598; Combination Product: Docetaxel |
| PART B. OCT-598 DL2 QD | Experimental | Administered orally, Combination with Docetaxel Receives: Drug: OCT-598; Combination Product: Docetaxel |
| PART B. OCT-598 DL3 QD | Experimental | Administered orally, Combination with Docetaxel Receives: Drug: OCT-598; Combination Product: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability by measuring the frequency and severity of adverse events, as assessed by CTCAE v5.0
Measured: Approximately 2 years
Incidence of Dose-Limiting Toxicities (DLTs) for Determination of the Maximum Tolerated Dose (MTD)
Measured: Approximately 2 years
Incidence of adverse events and dose-limiting toxicities used to determine the recommended Phase 2 dose (RP2D) of OCT-598 (PART B only)
Measured: Approximately 1 years
Secondary outcomes (3)
To assess the maximum observed plasma concentration (Cmax) of OCT-598.
Measured: Approximately 2 years
To evaluate the effect of food on the pharmacokinetics of OCT-598 by comparing Cmax under fed and fasted conditions.
Measured: From enrollment to Cycle 1 Day -3 (PART A only)
To measure time of maximum plasma concentration (Tmax)
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start18 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oscotec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358806
- Sponsor's protocol ID
- OSCO-P1401
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OCT-598 as a Single Agent and in Combination With Standard-of-Care Treatment in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07358806
- Acronym / sponsor ID
- OSCO-P1401
- Conditions
- Solid Tumor, Breast Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Gastric/Gastroesophageal Junction Cancer
- Keywords
- EP2/EP4 antagonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Oscotec Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 study intended to determine the MTD of OCT-598 following multiple-dose therapy and to establish the RP2D for OCT-598 as a single agent, by assessing its safety and tolerability as monotherapy and in combination with standard-of-care treatments in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| PART A. OCT-598 100mg QD | Experimental | Drug: OCT-598Administered orally |
| PART A. OCT-598 200mg QD | Experimental | Drug: OCT-598Administered orally |
| PART A. OCT-598 300mg QD | Experimental | Drug: OCT-598Administered orally |
| PART A. OCT-598 500mg QD | Experimental | Drug: OCT-598Administered orally |
| PART A. OCT-598 800mg QD | Experimental | Drug: OCT-598Administered orally |
| PART A. OCT-598 1200mg QD | Experimental | Drug: OCT-598Administered orally |
| PART B. OCT-598 DL1 QD | Experimental | Drug: OCT-598, Combination Product: DocetaxelAdministered orally, Combination with Docetaxel |
| PART B. OCT-598 DL2 QD | Experimental | Drug: OCT-598, Combination Product: DocetaxelAdministered orally, Combination with Docetaxel |
| PART B. OCT-598 DL3 QD | Experimental | Drug: OCT-598, Combination Product: DocetaxelAdministered orally, Combination with Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female or male, ≥18 years of age (or ≥19 years according to according to the local regulatory guidance), at the time of screening
- Signed informed consent prior to any study-related procedures that are not considered standard of care
- Life expectancy >12 weeks in the opinion of the investigator
- Adequate organ and marrow function, defined as follows:
- LVEF >50% or within institutional values
Key exclusion criteria (11 listed)
- Treatment with any IP or other anticancer therapy (including chemotherapy, antibody-drug conjugates, targeted agents, and immunotherapy) within 28 days or 5 half-lives, whichever is longer, of the first dose of study drug.
- Prior clinically significant treatment-related toxicities not resolved to Grade ≤1 or baseline (per CTCAE version 5.0) except for alopecia. Participants with stable Grade 2 peripheral neuropathy or endocrinopathies with stable endocrine replacement therapy are eligible. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study treatment (eg, vitiligo or hearing loss) may be eligible after discussion with the Sponsor.
- Prior treatment with an EP2 and/or EP4 antagonist.
- Major surgery or wide-field radiation within 28 days or limited field palliative radiation within 7 days prior to the first dose of the study drug.
- Known active central nervous system metastasis. Patients with asymptomatic previously treated brain metastasis are eligible if they are clinically stable for at least 4 weeks prior to enrollment and do not require treatment with corticosteroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT-598OCT-598 will be administered orally once daily. | Drug | PART A. OCT-598 100mg QD, PART A. OCT-598 1200mg QD, PART A. OCT-598 200mg QD, PART A. OCT-598 300mg QD, PART A. OCT-598 500mg QD, PART A. OCT-598 800mg QD, PART B. OCT-598 DL1 QD, PART B. OCT-598 DL2 QD, PART B. OCT-598 DL3 QD |
| DocetaxelDocetaxel will be provided for Part B only to support the combination therapy with the standard-of-care regimen. | Combination product | PART B. OCT-598 DL1 QD, PART B. OCT-598 DL2 QD, PART B. OCT-598 DL3 QD |
Primary outcome
To evaluate the safety and tolerability by measuring the frequency and severity of adverse events, as assessed by CTCAE v5.0
Time frame: Approximately 2 years
Incidence of Dose-Limiting Toxicities (DLTs) for Determination of the Maximum Tolerated Dose (MTD)
Time frame: Approximately 2 years
Incidence of adverse events and dose-limiting toxicities used to determine the recommended Phase 2 dose (RP2D) of OCT-598 (PART B only)
Time frame: Approximately 1 years
3 secondary outcomes
To assess the maximum observed plasma concentration (Cmax) of OCT-598.
Time frame: Approximately 2 years
To evaluate the effect of food on the pharmacokinetics of OCT-598 by comparing Cmax under fed and fasted conditions.
Time frame: From enrollment to Cycle 1 Day -3 (PART A only)
To measure time of maximum plasma concentration (Tmax)
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OCT-598 and Docetaxel in people with Solid Tumor and Breast Cancer, run by Oscotec Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sungsil Lee (82316287627, p1401@oscotec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability by measuring the frequency and severity of adverse events, as assessed by CTCAE v5.0 (time frame: Approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.